Lead Clinical Research Specialist

2 weeks ago

Trenton, New Jersey, United States Everest Clinical Research Full time


Everest Clinical Research is a comprehensive contract research organization (CRO) offering a wide array of expertise-driven clinical research services to global pharmaceutical, biotechnology, and medical device sectors.

We collaborate with renowned companies and engage with some of the most innovative drugs, biologics, and medical devices currently in development.

Since our establishment in 2004, Everest has maintained its independence as a CRO, building a robust foundation as a center of excellence in statistical and data management.

Expanding on this foundation, Everest has effectively evolved into a full-service CRO.

Our headquarters are situated in Markham, Ontario, Canada, with additional offices in Bridgewater, New Jersey, USA, Shanghai, China, and Taipei, Taiwan.

We are recognized in the industry for delivering high-quality results, exceptional customer service, and adaptability to meet client requirements.

As a dynamic organization with entrepreneurial roots, Everest continues to enjoy remarkable growth and success.
Quality is our cornerstone, customer-centricity is our legacy, and flexibility is our hallmark.

To sustain our success in this dynamic clinical research arena, we are looking for dedicated, skilled, and client-oriented professionals to join our esteemed team as Lead Clinical Research Specialists, focusing on the West Region.

The selected candidates may need to travel to various locations across the USA to support monitoring activities as required.

Key Responsibilities:


Engage with personnel from study Sponsors, investigational sites, vendors, and Everest functional teams to facilitate quality and timely execution of clinical trials in adherence to ICH-GCP and relevant local regulations.

Identify potential sites for participation in clinical trials.
Conduct protocol/site feasibility and Pre-Study Visits to recommend qualified sites.

Participate in Investigator Meetings, Clinical Research Associate (CRA) and Study Coordinator training sessions, and assist sites with study-related inquiries as necessary.

Provide input on study manuals, Case Report Form completion guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools, as required.

Conduct Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits in compliance with the approved protocol and monitoring plan.

Submit high-quality and timely Monitoring Visit Reports and follow-up letters to the Clinical Operations Lead or designee for review and approval via Clinical Trial Management System (CTMS).

Complete monitoring visit reports and follow-up letters, including summaries of significant findings, deviations, deficiencies, and recommended actions to ensure site compliance.

Assist with oversight visits and monitoring visit report review/approval of CRA I/II, evaluating their performance and providing feedback to their supervisor, if requested.

Review ISFs to ensure essential documents are current and submitted to the TMF throughout the trial for reconciliation purposes. Ensure sites have submitted relevant documents to their Institutional Review Board/Ethics Committee as needed. The CRA is responsible for ensuring that the TMF is maintained in an inspection-ready state.
Establish regular communication channels and administer ongoing protocol/study-related training to assigned sites.

Assist with site management tasks and ensure continuous data flow (i.e., on-time site data entry, query resolution, and source document verification).

Evaluate the clinical research site's patient recruitment/retention success and provide suggestions for improvement.
Ensure proper handling, accountability, and reconciliation of all investigational products, medical devices, and clinical trial supplies.
Prepare sites for inspections/audits conducted by regulatory authorities, Sponsors, or Contract Research Organizations.
Submit accurate and timely expense reports.
Assist with preparation of materials for Requests for Proposals and bid defenses.
Support the Clinical Operations team with additional related tasks as needed.
Plan and pursue professional development.
Complete timesheets as requested and on time.

Qualifications and Experience:
Bachelor's degree in a Life Science or related field of study.
Minimum of 4 years of relevant and/or monitoring experience.
Thorough knowledge of ICH-GCP guidelines and applicable regulations.
Comprehensive understanding of medical terminology.
Excellent organizational and communication skills (both verbal and written).
Ability to travel up to 70% of working hours to locations nationwide. Less travel hours may apply for projects with remote/virtual visits.
Must maintain a valid driver's license and be able to drive to monitor sites.
To learn more about Everest Clinical Research and explore other opportunities, please visit our website.
We appreciate all interested applicants; however, only those selected for an interview will be contacted.
Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity.

We welcome and encourage applications from individuals with disabilities, and upon request, we will provide accommodations for candidates participating in any part of our recruitment and selection process.


Qualifications Skills Behaviors :

Motivations :
Education Experience Licenses & Certifications Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

However, employees who have access to the compensation information of other employees or applicants as part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

41 CFR c)

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